Devices - GMDN search

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For IVDs scroll down to heading For IVDs only.

Medical Devices that are not IVDs

The selection of a GMDN code is a requirement of your Device Application.

The GMDN (Global Medical Device Nomenclature) Code is the world-wide recognised system for naming/identification of a medical device.

The GMDN code that you choose must accurately reflect your own device. Manufacturers should be referring to the GMDN agency database when selecting the appropriate GMDN codes for their Device.

Please note: You can use the TGA eBusiness system to search for and view the definitions of GMDN codes. However, the TGA GMDN code table in the TGA eBusiness system still includes expired GMDN codes or outdated definitions of GMDN codes for various functions associated with the regulation of medical devices and maintenance of the ARTG. The TGA is currently in the process of filtering new and expired definition, which occasionally show ‘<specifiy>’ as a marker indicating the code has not yet been updated to reflect the current status change.

Clicking on the ‘Search’ button will take you to the GMDN search screen.

The search field allows you to search by word or part word that may be used in the device name. The use of a part word or word may result in the listing of several device names.

You select the GMDN item by clicking on the preferred/correct line to highlight it.

Click on ‘Add to Application’ to insert the GMDN code into the eBusiness Device Application.


For IVDs only

A single GMDN Code and Description relevant to the IVD/s in the application must be selected.

For IVDs, Class 4 IVDs use GMDN term names. For Class 1-3 IVDs the selection of a suitable collective term (CT) is required. The same level of collective term should be used for the Class of the device, e.g. level 3 CT for a Class 3 device, level 1 CT for a Class 1 device. Where a level 3 collective term is not available for a Class 3 device a level 2 collective term may be used. The GMDN Agency website displays the appropriate explorer groups that are associated with the GMDN term name for the device (which should be available regardless of the Classification of the device for supply in Australia). Guidance regarding the use of collective terms can be viewed at: The use of GMDN codes for IVD medical devices in Australia

Page 2A (Class 1)
Class 1 IVDs that are for Export Only (Medical Device – IVD (Export Only) selection at Application for) – relevant Level 1 collective terms (GMDN codes CTxxx) are available for selection using the Search facility. If you do not know the GMDN code, enter into the search term field “IVDs” to produce a list of collective terms from which a selection can be made.

Class 1 IVDs for which an answer of ‘yes’ has been selected for Q60 (Does this application include any IVDs that are:…) - a single GMDN in a drop-down box is available for selection based on the answers provided for Q66-69 (questions that relate to the classification rules for Class 1 IVDs that are not for export only) on page one of the form.

Class 1 IVDs for which an answer of ‘no’ has been selected for Q60 (Does this application include any IVDs that are:…) – selection of one of the four Level 1 collective terms (GMDN codes CTxxx) available for these IVDs can be made from the drop-down box.

Page 2B (Other Classes)
Class 2 & 3 IVDs - relevant collective terms (GMDNs codes CTxxx or CTxxxx) are available for viewing and selection using the Search facility. If you do not know the GMDN code, enter into the search term field “IVDs” to produce a list of collective terms from which a selection can be made. For Class 2 IVDs, a Level 2 collective term must be selected. For Class 3 IVDs, a Level 3 collective must be used however if a Level 3 collective term does not exist, a Level 2 collective term may be used. See guidance for allocation of hierarchical levels to collective terms.

Class 4 IVDs that are immunohaematology reagents (IHRs) - relevant Level 2 collective terms (GMDNs codes CTxxx) are available for viewing and selection using the Search facility. If you do not know the GMDN code, enter into the search term field “IVDs” to produce a list of collective terms from which a selection can be made. Q63 (Does this application include Immunohaematology Reagents?) on the first page of the form must be answered in the positive to be able to select an appropriate GMDN collective term for your immunohaematology reagents.

Class 4 IVDs that are not immunohaematology reagents - relevant analyte-based GMDN term names (5-digit GMDN codes xxxxx) are available for selection using the Search facility. If you do not know the GMDN code, the analyte should be used to search for the GMDN, eg HIV1, HIV2, Hepatitis B. Q63 (Does this application include Immunohaematology Reagents?) on the first page of the form must be answered in the negative before you can select a GMDN preferred term to describe your product.

If after using the GMDN Search facility and reading the guidance document on IVD GMDNs you cannot find a particular code relevant to your application, contact the IVD team at devices@health.gov.au using the email subject ‘IVD team - GMDN’.